[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07564583":3,"trial-entities:NCT07564583":94,"trial-summary:NCT07564583":97},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":44,"secondary_outcomes":60,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":78,"locations":80,"central_contacts":90,"overall_officials":91,"references":92,"see_also_links":93},"NCT07564583","AAAV3403","Pilot Study of a Modified Safety Planning Intervention for Elementary School-Aged Children - Main Study","ENROLLING_BY_INVITATION","2026-12-31","2026-06","2026-06-29","2026-07-01","Columbia University","OTHER",true,"The goal of this study is to finalize a version of the Safety Planning Intervention suitable for 6-12-year-old children. This intervention provides individuals with strategies to reduce the risk of suicidal behavior.\n\nThe main questions it aims to answer are:\n\n1. Does the intervention appear clear and acceptable to the children and caregivers?\n2. Does the intervention work to reduce suicidal behavior? Researchers will compare the group that received the intervention to a group that did not receive it, and to a group that received it and reported daily on its use.\n\nParticipants will:\n\n1. Children and parents will respond to questions in an interview and through self-reports in an in-person meeting\n2. Children and parents will receive the intervention (those in the intervention groups)\n3. Parents will report daily for one month (only those in the intervention + reporting group)\n4. Children and parents will meet with the study team through a video call at 1 and 3 months from the first meeting for an interview.",null,[18,19],"Suicidal Ideation","Suicidal Behaviors",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},90,"ESTIMATED",[29,38],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":36},"BEHAVIORAL","Child - Safety Planning Intervention","The Child Safety Planning Intervention (C-SPI) provides psychoeducation to children and caregivers about emotions, thoughts, and behaviors, emphasizing how these interact and change over time. Suicidal thoughts are framed as temporary reactions to triggers that can be recognized and managed. The intervention reviews a recent suicidal crisis to identify triggers, thoughts, feelings, and behaviors, which are then used to help the child recognize warning signs in the future. These signs are organized into levels (green, yellow, red), each linked to specific action steps.",[34,35],"C-SPI + TAU + ecological momentary assessment","Child-safety planning intervention (C-SPI) + TAU",[37],"C-SPI",{"type":30,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"C-SPI+ecological momentary assessment","C-SPI and daily, self-reported use of C-SPI",[34],[43,37],"EMA",[45,49,53,57],{"measure":46,"description":47,"timeFrame":48},"Feasibility and acceptability of the C-SPI","Whether intervention is clear and perceived as helpful on a scale of 1-5 (higher score indicates better perception of helpfulness)","At baseline (following the intervention), and at 1 and 3 months follow-ups",{"measure":50,"description":51,"timeFrame":52},"Utilization of the C-SPI","Whether the C-SPI was used or not (0 or 1)","Daily for a month (through EMA), and at 1 and 3 month follow-ups",{"measure":54,"description":55,"timeFrame":56},"Suicidal behavior","Whether suicidal behavior was present and how many times (count variable beginning with zero; higher score indicating worse outcome)","1 and 3 months",{"measure":58,"description":59,"timeFrame":56},"Suicidal ideation severity","On a scale of 0-5 with higher score indicating worse outcome",[61],{"measure":62,"description":63,"timeFrame":56},"Mental health treatment engagement\u002Fservice utilization","Number of contact with mental health providers (count variable beginning with zero; higher score indicating better outcome)","ALL","6 Years","12 Years",false,{"inclusion":69,"exclusion":74,"raw_text":77},[70,71,72,73],"Children aged 6-12","Suicidal ideation with a plan or intent or a suicidal behavior in the last month","The child and their caregiver are English speakers","The child will be in an outpatient treatment at CHOP at the time of enrollment and baseline procedures",[75,76],"Child received a diagnosis of a psychotic disorder or intellectual disability","Child is suffering from active mania","Inclusion Criteria:\n\n* Children aged 6-12\n* Suicidal ideation with a plan or intent or a suicidal behavior in the last month\n* The child and their caregiver are English speakers\n* The child will be in an outpatient treatment at CHOP at the time of enrollment and baseline procedures\n\nExclusion Criteria:\n\n* Child received a diagnosis of a psychotic disorder or intellectual disability\n* Child is suffering from active mania",[79],"CHILD",[81],{"facility":82,"city":83,"state":84,"zip":85,"country":86,"geoPoint":87},"Children Hospital of Philadelphia","Philadelphia","Pennsylvania","19104","United States",{"lat":88,"lon":89},39.95238,-75.16362,[],[],[],[],{"nct_id":4,"conditions":95,"biomarkers":96},[54,18],[],{"nct_id":4,"found":67,"summary":16,"prompt_version":16}]